In this research effects of mucoadhesive paste contains olive leaf extract on treatment of aphthous ulcers compared to tropical corticosteroid drug is investigated. All patients with recurrent aphtus ulcers referring to clinic of dentistry school, Zahedan University of Medical Sciences who have the inclusion criteria and have not exclusion criteria are entered in this research. The patients with RAS are assigned to treatment group (mucoadhesive paste contains Olive leaf extract), Tropical glucocorticoid (mucoadhesive paste contains triamcinolone) and placebo group (mucoadhesive paste without any drug) by using a computer-generated random number list (N=26 in each group). The treatment and the placebo agents were packed in identical looking containers and labeled with a code number A or B or C randomly (named agents A, B and C) and the patient and dentist are blinded about the groups. Instruction of drug usage in all groups is 4 times per day, 3 times prior each meal and the last time, 20 min prior the sleeping. Evaluation and photography of ulcers are done in 0, 1, 2, 5 and 7th days from beginning of the experiment. Area of ulcer is estimated using Cavalieri’s point counting method and to evaluate pain, a visual analog scale (VAS) is used. The effectiveness indices of the ulcer size and pain improvement are calculated with the formula and comparisons are done.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015080723542N1
Registration date:2015-09-12, 1394/06/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-09-12, 1394/06/21
Registrant information
Name
Zahra Heidari
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5796
Email address
heidari@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Grant from Zahedan University of Medical Sciences
Expected recruitment start date
2015-09-30, 1394/07/08
Expected recruitment end date
2016-04-30, 1395/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of mucoadhesive paste contains olive leaf extract in the treatment of Recurrent Aphthous stomatitis (RAS) compared with topical corticosteroid
Public title
Effects of mucoadhesive paste contains olive leaf extract in the treatment of Recurrent Aphthous stomatitis (RAS) compared with topical corticosteroid
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having 1-5 minor aphthous ulcer and their ulcers diameter were less than 5mm; having pain, without unusual sense of paresthesia and anesthesia; filling informed consent form for participation in this study.
Exclusion criteria: having a history of drug hypersensitivity; pregnancy and breast feeding; having the history of systemic disorders or Behcet,s syndrome; receiving any other drug comprising NSAIDs or antihistamines in last 1 month; receiving any other drug for curing the ulcers from 72 hours prior the beginning the study; receiving systemic antibiotics from 2 weeks prior the beginning the study; Aphthous ulcers nearby trauma from sharp-edged teeth, broken restorations, orthodontic appliance or partial denture
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Zahedan University of Medical Sciences
Street address
Pardis of Zahedan University of Medical Sciences
City
Zahedan
Postal code
98168-43175
Approval date
2015-08-02, 1394/05/11
Ethics committee reference number
IR.ZAUMS.IRC.1394.219
Health conditions studied
1
Description of health condition studied
Recurrent oral Aphthous
ICD-10 code
K12.0
ICD-10 code description
Recurrent aphthous ulcer
Primary outcomes
1
Description
surface of the ulcer
Timepoint
days 0, 1, 2, 5, and 7
Method of measurement
by stereological method of point counting method of cavalieri on ulcer photographs
2
Description
pain
Timepoint
days 0, 1, 2, 5, and 7
Method of measurement
VAS ruler of pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: mucoadhesive paste contains Olive leaf extract. Instruction of drug usage is 4 times per day, 3 times prior each meal and the last time, 20 min prior the sleeping. Evaluation and photography of ulcers are done in 0, 1, 2, 5 and 7th days from beginning of the experiment. Area of ulcer is estimated using Cavalieri’s point counting method and to evaluate pain, a visual analog scale (VAS) is used.
Category
Treatment - Drugs
2
Description
Positive control group:Tropical glucocorticoid (mucoadhesive paste contains triamcinolone) with the same instruction that used in interventional group.
Category
Treatment - Drugs
3
Description
Negative control group: mucoadhesive paste without any drug with the same instruction that used in interventional group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry
Full name of responsible person
Zahra Heidari
Street address
School of Dentistry, Zahedan University of Medical Sciences, Zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of Research and Technology of Zahedan University of Medical Sciences
Full name of responsible person
Dr Rafighdoost
Street address
Padis of Zahedan University of Medical siences
City
Zahedan
Grant name
گرنت
Grant code / Reference number
7427
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Research and Technology of Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Zahra Heidari
Position
Ph.D/ Pofessor
Other areas of specialty/work
Street address
School of Medicine, Zahedan University of Medical Sciences, Zahedan
City
Zahedan
Postal code
98168-43175
Phone
+98 54 3329 4390
Fax
+98 54 3329 4390
Email
histology@ymail.comhistology_iri@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Zahra Heidari
Position
Ph.D/ Professor
Other areas of specialty/work
Street address
Histology department, School of medicine, Zahedan University of Medical Sciences, Zahedan
City
Zahedan
Postal code
98168-43175
Phone
+98 54 3329 4390
Fax
+98 54 3329 4390
Email
histology@ymail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Zahra Heidari
Position
Ph.D/Professor
Other areas of specialty/work
Street address
Histology department, School of medicine, Zahedan University of Medical Sciences, Zahedan
City
Zahedan
Postal code
98168-43175
Phone
+98 54 3329 4390
Fax
+98 54 3329 4390
Email
histology@ymail.com; histology_iri@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)